Ms. Bicky Nyeleti
With over 17 years of diverse experience in the clinical trial field, Ms. Bicky currently works as a freelancer, serving as the Director at a CRO named AfriLeadTech Research (PTY) LTD and holding the position of Chairperson at The South African Clinical Research Association (SACRA). Ms. Bicky is driven by a passion for growth and excellence within the clinical research industry. Her journey has encompassed various leadership roles, including Project Operations Director, Local Clinical Trial Manager, and Regional Study Manager across Africa, Asia, and Europe.
A Results-Driven Project Manager:
Ms. Bicky excels in overseeing and managing project operations both locally and globally. As the Project Operations Director, she led a team of dedicated Project Managers and successfully delivered high-priority services to valued clients.
Seasoned Clinical Trial Regulatory Expert:
Ms. Bicky’s expertise lies in regulatory matters; her entry into the clinical research field began with SAHPRA when it was called MCC. Specializing in streamlining regulatory processes and timelines, she ensures a seamless and efficient journey. With a keen eye for detail, she manages intricate regulatory requirements, documentation, and communication with authorities. Leveraging her strategic insight and extensive expertise, she accelerates the initiation and progress of clinical trials in South Africa.
Training, Quality, and Compliance:
Ms. Bicky takes pride in crafting comprehensive SOPs and training programs for CROs and Research Sites. Notably, she developed a 6-month CRA Training Program and Accredited GCP material.
Driving Ethical Research Practices:
With a profound understanding of ethical guidelines, including GCP and the Declaration of Helsinki, Ms. Bicky collaborates with ethics committees and IRBs to ensure ethical conduct in clinical research. Currently, she leads the SACRA input to the ICH GCP R3.
SACRA Chairperson | Strategist and Ethical Advocate | Entrepreneur:
As the SACRA Chairperson, Ms. Bicky advocates for clinical trials and mentorship programs, consistently sharing knowledge and staying updated about the latest changes in the clinical trial landscape. Leading the SACRA international clinical trials day for the past three years stands out as a career highlight. Functioning as a strategist, enthusiast, and entrepreneur in clinical research, she founded a flourishing clinical research site that contributes significantly to capacity building in South Africa.